Use of a Video-based, Personalized Web Page as a Complement to Standard Patient Education for Clinical Trial Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Number of cumulative participant caused violations over 4 cycles
研究概览
简要总结
This research study is evaluating the effectiveness of video and web-based communication in clinical research compared to standard practices.
详细描述
Research has shown that many clinical trial participants are confused about clinical trials. Common participant misunderstandings include the idea of randomization, benefits to participants' health, the proven nature of the study intervention, and failure to recognize the primary purpose of the trial. There can sometimes be unintended miscommunication between the study doctor and/or nursing staff and participants. Thus, there is a clear need to identify ways to improve communication during clinical trials. The investigator's current culture of web-based information presentation, whether it takes the form of PowerPoint presentations, videos, websites, or audio tools, suggests that adding such technology to the cancer research realm may improve a participant's clinical trial experience and possibly improve participant understanding and safety while enrolled on a clinical trial. Video and web-based tools in cancer research have the potential to transform clinical trial practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Postwire© Virtual Education Cohort
- Participants will be administered a brief questionnaire that asks questions about participant internet access, use, and understanding (Appendix B). This questionnaire will be used to determine eligibility.
- In randomized into the Virtual Education Cohort:A video based, personalized web page will be created that has information related to the participants therapeutic clinical trial.
- This web page will have videos of a research nurse explaining how to take study medication(s), how to fill out the study drug diary, and a description of the main side effects associated with the study drugs.
- Clinic Visit Video Recording Cycle 1-4/Day 1
- Participants from both groups will be asked to complete two surveys before each Day 1 clinic visit for Cycles 1-7
干预措施: Postwire (Other)
No Video Intervention
Participants will be administered a brief questionnaire that asks questions about participant internet access, use, and understanding (Appendix B). This questionnaire will be used to determine eligibility
- Participants randomized to the control cohort will follow standard of care procedures involving clinic visits that do not include the use of video or access to a personalized web page.
- Participants from both groups will be asked to complete two surveys before each Day 1 clinic visit for Cycles 1-7.
结局指标
主要结局
Number of cumulative participant caused violations over 4 cycles
时间窗: 168 Days
Wilcoxon Rank Sum Test (one-sided alpha = 0.10).
次要结局
- Participant reported outcomes (PRO) center on treatment satisfaction(PROs collected on Cycle 1 Day 1 and each day 1 of a cycle thereafter until Cycle 7 Day 1, approximately over the course of 7 months.)
- Number of times participants accessed the webpage(126 Days)
- number of participant-caused protocol violations(168 Days)
- Participant reported outcomes (PRO) on Perceived Stress(PROs collected on Cycle 1 Day 1 and each day 1 of a cycle thereafter until Cycle 7 Day 1, approximately over the course of 7 months.)
研究者
Mary-Ellen Taplin, MD
Prinicipal Investigator
Dana-Farber Cancer Institute